| IAP Guidebook on Immunization |
| Table of Contents | Committee on Immunization | |
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| Non UIP Vaccines Mumps Vaccine Mumps Vaccine can be prevented by vaccination given either as a monovalent vaccine or as part of MMR vaccine. A live attenuated monovalent Mumps vaccine was first developed by Hilleman in 1966. The mumps component in MMR vaccine contains live attenuated Mumps virus not less than 5000 TCID per dose. A live attenuated Rubella vaccine was developed by Waller in 1962. The current rubella vaccine available commercially is derived from RA 27/3 vaccine strain grown in human diploid cell cultures. It is available either as a monovalent vaccine or as a part of combination vaccine – MMR. It contains live attenuated virus not less than 1000 TCID50. It is a highly immunogenic vaccine with positive antibody response in 95% of susceptible vaccinees. It provides long term and probably life long protection and vaccine failures are uncommon. Summary: Rubella and Mumps Vaccine
Summary: Prevention of Congenital Rubella
MMR Vaccine is available as single as well as multidose (5 dose) vial. The diluent for injection is available separately. The dose of the reconstituted vaccine is 0.5 ml per dose, to be administered subcutaneously in the upper arm. The vaccine should be stored between +2 to +8oC in the ordinary compartment of the fridge. Reconstituted vaccine should be used within 6 hours. At present, IAP recommends a dose of MMR vaccine to all children. For infants given Measles vaccine at 9 months, MMR vaccine may be given between 12-15 months of age. If Measles vaccine is given later, a 3 months gap is advisable. If Measles vaccine was missed altogether, one MMR dose replaces it, when given at or after 12 months. The vaccine can be given along with any other vaccine like DPT, OPV but at different sites using different syringes and needles. In India, 3-7% of individuals, from school age upwards, are found to be chronic carriers of Hepatitis B Virus (HBV). In their blood, Hepatitis B surface antigen (HBsAg) test is positive. Infection with HBV may occur perinatally (vertical transmission), during early childhood (usually intrafamilial spread), through sexual contact, or nosocomially. The younger the age of infection, the higher the chance of becoming chronically infected as carrier. Children usually do not get acute icteric hepatitis with HBV infection. Therefore, pediatricians do not see the consequences of the prevalence of HBV infection. HBV is the major cause of chronic hepatitis, cirrhosis of liver and hepatocellular carcinoma. These are all preventable by early childhood immunization. The World Health Organization recommends universal Hepatitis B Vaccination. Hepatitis B vaccine should be given IM at antero-lateral thigh in infants. In older children/adults it should be administered at deltoid region. As an adjuvanated vaccine, it should not be frozen. If frozen accidentally, the vaccine should be discarded. It should be injected intramuscularly, avoiding the gluteal region since it has been shown to be sometimes less immunogenic at this site. It is believed that the microgram dose of HBsAg might be deposited within the fat tissue, thereby reducing its bioavailability to antigen-presenting cells. For children with bleeding diathesis, special care to be taken by applying pressure for 5 to 10 minutes at the site of injection under careful medical supervision.
Routine screening of pregnant women for HBV carrier state should be
done where ever feasible. If the mother is found to be a carrier and especially so
for e antigen carrier, the baby must be protected with passive immunization
soon after birth with Hepatitis B immunoglobulin given within 12 hours of birth.
When HBIG is not available, good protection, i.e. over 95% of efficacy in terms
of preventing either infection per se, or at least preventing the development of
chronic infection (carrier state), can be achieved by active immunization alone.
Vaccine should be given as soon as possible, preferably within 12 hours of birth.
Since 3-7% of all mothers are likely to be HBV carriers, the ideal time to commence
HB immunization is at birth, or as early as possible, preferably within 12 hours. Using the principles described, the IAP recommends the commencement of HB immunization at birth. Two alternate schedules are available:-
Summary HB Vaccine
Types of Vaccine
Storage, route, dosage and efficacy
 HBIG provides immediate passive immunity for those individuals with acute exposure to HBsAg positive blood/blood derivatives. Clinical trials have demonstrated reduction in attack rate of clinical hepatitis B following its use. After administration of the usual recommended dose of the HBIG there is a detectable level of circulating anti-HBsAg antibody which will persist for 3 months. No case of transmission of hepatitis B has been associated with the use of this product anywhere in the world. HBIG does not interfere with generation of antibody response to hepatitis B vaccine. Ideally, persons known to be exposed to blood which is known to contain hepatitis B virus should be given combined passive – active immunization. Adverse Effects: Transient, mild pain at the site of injection, itching are the common side effects in a small proportion of recipients. Contraindication: No specific contraindications. Special Precautions: More as a precautionary measure, some experts recommend caution when administering HBIG to humans with history of previous systemic allergy subsequent to administration of immunoglobulin preparations. Hepatitis B Immunoglobulin should never be administered intravenously. It should be always given intramuscularly. The needle should not be in a blood vessel and this should be ascertained by drawing back the plunger of the syringe. Indications: For prophylaxis of hepatitis B after exposure to HBsAg, e.g. by accident “needle –stick”, contact by accidental splash or oral ingestion (pipetting accident) involving HBsAg positive materials such as blood, plasma or serum. For prophylaxis of hepatitis B in neonates born to HBsAg positive mothers. Dosage: Following exposure to HBsAg. Adults: 1000 – 2000i.u., I.M. Children: 32-48 i.u.,/kg body wt. This should be administered within 7 days (preferably within 48 hrs) after exposure to HBsAg. Neonates: Initial dose is 100 – 200 i.u. The first dose should be administered within 5 days after birth. The booster dose should be 32 – 48 i.u./kg of body wt., between 2 & 3 months after initial dose. Typhoid fever is widely prevalent in India and 3 fairly good vaccines are available. The choice of vaccine depends upon the age of commencement of the vaccine and the availability.
Summary: Typhoid Vaccine
Haemophilus influenzae type b vaccine is a very effective and safe vaccine. Hib is an important pathogen causing meningitis and pneumonia in infants and children below 2-3 years. Both PRP-T and PRP - CRM 197 conjugate Hib vaccine are now available in India. As Hib disease is age dependant and Hib immunization involves boosting of natural immunity, 3 doses when initiated below 6 months, 2 doses between 6 to 12 months and 1 dose between 12 to 15 months should be given. A booster is recommended at 15 to 18 months. Beyond 18 month a single dose is recommended upto 5 years of age and above 5 years Hib vaccination is not recommended. Summary: HIB Vaccine
HIb Vaccine Recommended Schedule  Japanese B Encephalitis Vaccine The Indian strain of the Japanese B Encephalitis vaccine produced by Central Research Insititute, Kasauli, Shimla, is available through central and state health authorities for use in endemic areas during epidemic situation in the specific regions of the country where the infection is prevalent. For details on dosage and time of administration the instructions issued by the manufacturer and the local health authorities should be scrupulously followed. It is used for active immunization against Neisseria meningitidis infection which includes meningitis and septicaemia. It is a bivalent vaccine containing antigens of sero types group A & C of N. Meningitidis. Each 0.5 ml dose contains purified polysaccharide of N. meningitidis group A 50 mcg and group C 50mcg. Minimum recommended age of administration is usually 2 years because of possible poor immune response in younger infants. Adverse Effects: Low grade fever. Pain at injection site. Contraindications: Acute infectious diseases. Special Precautions: Meningitis caused by other meningococcal groups. Children below two years. Indications: Prophylaxis against cerebrospinal meningitis due to meningococcal A & C groups in persons at risk in epidemic and endemic areas. It is given as an adjunct to chemoprophylaxis in close contacts of persons with the disease. It should also be considered for people travelling to countries where the disease is endemic. Dosage: Single 0.5ml S.C. or I.M. injection. This guidebook describes in detail vaccines that IAP recommends for current use. There are two other vaccines that have recently been introduced in India. They are live attenuated Varicella vaccine and killed Hepatitis A virus vaccine. At present IAP committee on Immunization consider these vaccine as additional vaccines. However, both are excellent vaccines- highly efficacious and very safe. Chicken Pox is a self limiting disease affecting mostly children and young adults, however complications of varicella are often seen in immunocompromised children adolescents, adults and pregnant women. Takahashi et al developed the live attenuated vaccine from Oka strain in Japan. The product contains trace amounts of neomycin and gelatin. The vaccine can be administered to any healthy individual above the age of 12 months who have not had varicella. The recommended dose is 0.5 ml which provides at least 1350 plaque forming units of the virus. The vaccine is administered subcutaneously in the upper arm/thigh region. The vaccine is recommended after the age of 1 year. Upto the age of 12 years, one dose is required and if given after 12 years, 2 doses are needed at an interval of 1 month. Both humoral and cell mediated immunity develops in more than 95% cases after a single dose between 1-12 years and 99% after 2 doses in children 13 years and above. Summary: Varicella Vaccine
Hepatitis A is a relatively benign infection in children. About 85% of HAV infection in children 1-2 years old, 50% between 3-5 years and 20% above the age of 5 years are asymptomatic. Mortality due to hepatitis A specially in children is rare. The disease severity increases, irrespective of age in those with underlying liver disease. The virus was first cultured by Provost and Hilleman in 1979. Since 1980, inactivated vaccine is available. Presently, the HA vaccine available in India is of HM 175 strain grown on MRC5 cell line The vaccine is recommended after 2 years of age when maternal antibody declines. In children less than 18 years of age, pediatric formulation containing 720 Enzyme Linked ImmunoAssay units (ELU) containing 0.5 ml per dose is administered intramuscularly on 0 and 6 months. In 19 years and older 1440 ELU in 1 ml is injected at 0 and 6 months (0 being the elected date). The vaccine efficacy is 94-100% and the duration of protection is long lasting, hence no booster dose is recommended at present. Although manufacturers recommend Hepatitis A vaccine after one year of age, IAP recommends that it should be given after 2 years for optimal immune response. It has been observed from various Indian data that till one and half year of age, maternal antibody persist which may adversely affect seroconversion. Summary: Hepatitis A Vaccine
Streptococcus pneumoniae is a ubiquitous organism and colonizes the throats of upto 91% children of 6 months to 5 years of age. The bacterial capsule contains complex polysaccharide which forms the basis of classifying pneumococci into 85 serotypes. Common pathogenic serotypes in children are 1, 4, 5, 6, 9, 11, 14, 15, 18, 19 and 23. However, the prevalence of the serotypes differ from country to country and region to region. A recent multicentric trial from India has demonstrated 6, 1, 19, 14, 4, 5, 45, 12 & 7 as the common serotypes responsible for invasive disease in children below 5 years of age. Serotypes 1, 6 & 19 accounted for 46% of childhood invasive disease. Two types of vaccine are currently available – a 23 valent polysaccharide vaccine (available in India) and a 7 valent conjugate polysaccharide vaccine in some countries of the world. 23-valent polysaccharide vaccine is capable of prevention of 85% of meningitis and bacteremia caused by pneumococcus. Each dose is 0.5 ml containing 25 ug of individual serotype polysaccharide. A single intramuscular injection is recommended after the age of 2 years with booster every 3-5 years till the age of 10 years. Immunization is not effective against otitis media since prevalent serotypes causing ear infection is not included in the vaccine. The vaccine is not routinely recommended but is indicated in special situations. Summary: Pneumococcal Vaccine
Indications
Influenzae virus belongs to orthomyxovirus of 3 antigenic types (A, B & C) with several subtypes of each based on 2 surface antigens e.g. hemagglutinin and neurominidase. There is frequent antigenic shift of the virus more with type A and therefore it is of utmost importance to find out the prevalence of the particular type of the virus with subtypes so that appropriate vaccine can be produced for that region and country. The inactivated influenza vaccine produced in embryonated eggs are immunogenic and associated with minimal side effects. These multivalent vaccine usually contain 3 virus strains (usually 2 type A and 1 type B) with composition changed periodically in anticipation of the prevalent influenza strains expected to circulate in the country. The vaccine is given in 2 doses in children 6 months to 9 years of age and one dose above 9 years of age. The dose is 0.25 ml between 6 months to 3 years IM and 0.5 ml after the age of 3 years. The vaccine is not routinely recommended in India since the prevalent antigenic types are not known. However, in some high risk children and adolescents, the vaccine may be helpful. The vaccine is effective for only short period (6 month to 1 year). Summary: Influenzae Vaccine Targeted High Risk Groups
Rabies is the most dreaded disease known to mankind, once the disease occurs, it invariably leads to death. Rabies virus is a RNA virus classified as Rhabdovirus family. Rabies occurs due to the bite of rabid animals. In India almost all the rabies cases occur due to the bites of dog. The incubation period averages 4-6 weeks but ranges from 5 days to more than 1 year. There are 2 types of vaccines available in India
Nerve tissue vaccine is no longer recommended because of its poor efficacy and life threatening adverse reactions in the form of neuroparalytic conditions of 1:2000 to 1: 8000 doses. Tissue culture vaccines
Post exposure prophylaxis The vaccine is administered 1 ml/dose irrespective of age intramuscularly in the deltoid region in infants more than 2 years on days 0, 3, 7, 14 and 28. The day on which first injection is commenced is considered as 0. In infants less than 2 years, anterolateral aspect of thigh is used for injection. Do not inject in gluteal region. For re-exposure, within 5 years - 2 doses - Day 0 - 7, after 5 years - full course of 5 injections or earlier whenever the antirabies antibody titer falls below 5 IU/ml. Pre-exposure prophylaxis
Summary: Rabbies Vaccine
Post exposure Prophylaxis
Pre exposure Prophylaxis
It is a liquid or freeze – dried preparation containing immunoglobulins mainly IgG obtained from plasma or serum of donors immunised against rabies and contains specific antibodies that neutralise the rabies virus. It is prepared from plasma or serum of not fewer than 1000 donors. It contains not less than 150 units / ml. It provides passive protection when given immediately to individuals exposed to rabies virus. This provides maximum circulating antibody with minimum interference of active immunization with human diploid – cell vaccine.
Adverse Effects: Local tenderness, muscle soreness or stiffness at the injection
site, low grade fever, sensitization to repeated injections of human globulin in
immunoglobulin deficient patients.
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